Renan

Teach about ADR's in pharmacy school. What are you specifically looking at here?

Hi Barry,

Thanks for your message!

Could you share names of any article/book about how ADRs information is shared by and managed between different healthcare and science professionals.

Best,

Renan

In a nutshell is not shared. ADR's have been hidden, denied and downplayed for years because pharma companies have valued profits over patient safety. I recommend Marcia Angel's The Truth About The Drug Companies and David Healy's The Creation of Psychopharmacology.

You should also look up the works of Andrew Herxheimer.

Hee is a list of useful references:

Andrews, E.B., Moore, N. (2014) Mann’s Pharmacovigilance, New York, USA: John Wiley & Sons, Ltd, 11 – 24.

Attarwala, H. (2010) TGN1412: From Discovery to Disaster, Journal of Young Pharmacists, 2(3), 332 – 336.

Bavec, A. (2014) Insulin, Other Hypoglycaemic Drugs and Glucagon. A worldwide yearly survey of new data in a adverse drug reactions. Side effects of Drugs Annual, 36, 645 – 657.

British Pharmacological Society (2019), Prescribing and patient safety. Available from: https://www.bps.ac.uk/education-engagement/prescribing-and-patient-safety [accessed 20 December 2019]

Caron, J., Rochoy, M., Gaboriau, L. and Gautier, S. (2016) The history of pharmacovigilance. Therapie, 71(2), 129 – 134.

Charfi, R., El Aidi, S., Zaiem, A., Kastali, S., Srairi, S., Daghfous, R. and Lakhal, M. (2012) Serious adverse drug reactions in older adults notified to Pharmacovigilance. Therapie, 67(5), 465 – 470.

European Medicines Agency, EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers, 2019. Available from: https://www.ema.europa.eu/en/news/eu-us-reach-milestone-mutual-recognition-inspections-medicines-manufacturers [accessed 20 December 2019].

Evans, S.J.W., Waller, P.C. and Davis, S. (2001) Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and drug safety, 10, 483 – 486.

Faillie, J.L., Montastruc, F., Montastruc, J.L. and Pariente, A. (2016) Pharmacoepidemiology and its input to pharmacovigilance. Therapie, 71(2), 211 – 216.

Food and Drug Administration (2019), Part I: The 1906 Food and Drugs Act and its enforcement, United States.

LePendu, P., Iyer, S., Bauer – Mehren, A., Harpaza, R., Mortensen, J., Podchiyska, T., Ferris, T. and Shah, N. (2013) Pharmacovigilance using clinical notes. Clinical Pharmacology and therapeutics, 93(6), 547 – 555.

Light, D.W. (1997) The real ethics of rationing. BMJ, 315, 112 – 117.

Muscholl, E. (1995) The evolution of experimental pharmacology as a biological science: the pioneering work of Buchheim and Schmiedeberg. British Journal of Pharmacology, 116(4), 2155 – 2159.

Pontes, C., Zara, C., Torrent – Farnell, J., Obach, M., Nadal, C., Vella – Bonanno, P., Ermisch, M., Simoens, S., Hauegen, R.C., Gulbinovic, J., Timoney, A., Martin, A.P., Mueller, T., Nachtnebel, A., Campbell, S., Selke, G., Bochenek, T., Rothe, C.C., Mardare, I., Bennie, M., Furst, J., Malmstrom, R and Godman, B. (2019) Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab. Applied Health Economics and Health Policy.

Routledge, P. (1998) 150 years of pharmacovigilance. The Lancet, 351(9110), 1200 – 1201.

Anderson, C., Gifford, A., Avery A., Fortnum, H., Murphy, E., Krska, J and Bond, C. (2011) Accessing the usability of methods of public reporting of adverse drug reactions to the UK Yellow Card Scheme. Health Expectation 15(4) 337-448.

Barnes, J., Mills, S., Abbot, N., Willoughby, M. and Ernst, E. (1998) Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. British Journal of Clinical Pharmacology, 45(5) 496-500.

Chaplin, S. (2018) Monitoring drug safe: is the Yellow Card Scheme struggling?. Available from https://onlinelibrary-wiley-com.proxy.library.lincoln.ac.uk/doi/pdfdirect/10.1002/psb.1789 [accessed 3 December 2019]

Chaplin, S. (2006) The Yellow Card scheme – why are GPs under-reporting?. Available from https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/psb.405 [accessed 4 December 2019]

Cox (2007) Adverse Drug Reaction reporting to The Yellow Card Scheme. Birmingham: Aston University. Available from https://publications.aston.ac.uk/id/eprint/11068/1/Cox_AR_2007.pdf [accessed 9 December 2019]

Eland, I., Belton, K., Van Grootheest, A., Meiners, A., Rawlins, M. and Stricker, B. (1999) Altitudinal survey of voluntary reporting of adverse drug reactions. British Journal of Clinical Pharmacology, 48(4) 623-627.

European Commission (2009) Diretive 2001/20EC of the European Parliament and of The Council of 4 April 2001. Brussels: European Commission. Available from https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf [accessed 9 December 2019]

European Medicines Agency (2019) Medicines under additional monitoring. Amsterdam: European Medicines Agency. Available from https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring [accessed 4 December 2019]

Herxheimer, A., Crombag, R. and Alves, T. (2010) Direct Patient Reporting of Adverse Drug Reactions. Amsterdam: Health Action International Europe. Available from https://consumers.cochrane.org/sites/consumers.cochrane.org/files/public/uploads/10%20May%202010%20Report%20Direct%20Patient%20Reporting%20of%20ADRs.pdf[accessed 4 December 2019]

Khandeparkar, A. and Rataboli, P. (2017) A study of harmful drug-drug interactions due to polypharmacy in hospitalized patients in Goa Medical College. Perspectives in Clinical Research, 8(4) 180-186.

Krska, J., Anderson, C., Murphy, E, and Avery, A (2011) How Patient Reporters Identify Adverse Drug Reactions. Drug Safety, 34(5) 429-436.

MHRA (undated) Yellowcard. London: MHRA. Available from http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con036033.pdf [accessed 9 December 2019]

This is absolutely GREAT, Barry!

Thank you very much, it's gonna be pretty useful!

Cheers!

Renan

Wow, Barry, Renan can now go wild.

Those are the most important references.

I recall the frustrations of a US doctor who penned that as:

Death by Prescription - Dr Ray D Strand